Weir Regulatory Consulting can provide assistance with the following:
- Regulatory strategy for timely product registration
- Dossier review and gap analysis
- TGA pre-submission meetings
- Preparation of dossier for registration with TGA and/or Medsafe, including NCE, NBE, literature-based (LBS) or hybrid submissions (Category 1 applications)
- Major and minor variations including Category 3 applications
- GMP clearance for overseas manufacturers
- Guidance with technical transfers/change to manufacturing sites
- Promotional and advertising advice including claim review, in line with Medicines Australia Code of Conduct
- Medical device registration including Conformity Assessment and guidance with manufacturers evidence
- Review of processes and procedures/SOPs
- Guidance and interaction with Regulatory agencies
- Orphan drug registration
- Import permits including AQIS, controlled substances
- Preparation of compliant labelling including PI, CMI and artwork